Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
Data Integrity ensures data's accuracy and consistency over its lifecycle, crucial in pharmaceuticals per EU GMP. ALCOA summarizes key principles for data recording. ALCOA+ extends with four more principles for a comp...
Jaap Koster
CEO / Senior GxP Consultant
A blog post on the “Clothier Report”. This report was commissionned by the Secretary of State for Social Services of the United Kingdom in March of 1972. The report is named after it’s chairman; C. M. Clothier.
Jaap Koster
CEO / Senior GxP Consultant
The blog post suggests a structured approach to analyze and address these errors, including understanding human behavior and creating a blame-free culture. It underlines the importance of proactive solutions over reac...
Jaap Koster
CEO / Senior GxP Consultant
This blog emphasizes the importance of clear, concise, and practical batch records to avoid operator errors. The article highlights the challenges posed by overly lengthy or outdated batch records, suggesting a need f...
Jaap Koster
CEO / Senior GxP Consultant
Well-designed batch records are crucial for efficient production, complying with regulations, and promoting data integrity.
Jaap Koster
CEO / Senior GxP Consultant
Creating perfect GMP Batch Records can be challenging due to human factors and company culture. Establishing a safe environment for employees to report errors and leading by example are crucial for success.
Jaap Koster
CEO / Senior GxP Consultant
Avoid common pitfalls in human error handling. Duct tape solutions and excessive procedures don't work. Understand the cause and design error-proof systems.
Jaap Koster
CEO / Senior GxP Consultant
Working in a GMP cleanroom is challenging. Qualifying aseptic operators requires experience, training, and ongoing monitoring. Gowning, monitoring and behavior are crucial.
Jaap Koster
CEO / Senior GxP Consultant
What is GMP? The WHO defines GMP as preventing errors that can't be eliminated through QC of the finished product. Learn about the ten golden rules of GMP.
Jaap Koster
CEO / Senior GxP Consultant
"Exploring the debate between Planned vs. Unplanned Deviations in GMP. Let's focus on real issues like drug shortages, not semantics.
Jaap Koster
CEO / Senior GxP Consultant
Transporters storing medicinal products >72 hours can get a WDA (GDP license). Under 72 hours storage doesn't qualify for WDA or GDP certificate. Voluntary GDP adherence is an option for client satisfaction.
Jaap Koster
CEO / Senior GxP Consultant
The Critical Role of Proper Deviation Management in the Pharmaceutical Industry: Explore the importance of deviation and CAPA management, including impact assessments and root cause analysis, to ensure product quality...
Jaap Koster
CEO / Senior GxP Consultant
Learn about Manufacturing and Import Authorizations (MIAs) in the pharmaceutical industry, essential for importing or manufacturing medicines in the EU.
Jaap Koster
CEO / Senior GxP Consultant
The Elixir Sulfanilamide disaster was a tragic event that occurred in 1937, resulting in the deaths of over 100 people, many of them children.
Jaap Koster
CEO / Senior GxP Consultant
Tips for conducting in-depth GMP or GDP audits: Understand different levels of inspection-depth: absence, adherence, and adequacy. Use intellect and intuition to spot issues. Classify findings as critical, major, or m...
Jaap Koster
CEO / Senior GxP Consultant
This blog explores the Tenerife disaster's lessons on human error and communication, drawing parallels to the pharmaceutical industry. It emphasizes the need for clear communication, standardized protocols, and a safe...
Jaap Koster
CEO / Senior GxP Consultant
WDA, or Wholesale Distribution Authorization, is crucial in the pharmaceutical industry. It's required for storing medicinal products for over 72 hours. Learn how to obtain it and navigate post-Brexit regulations for...
Jaap Koster
CEO / Senior GxP Consultant
Navigating the complex landscape of obtaining a Wholesale Distribution Authorization (WDA) license is no easy feat, especially for startups. However, cutting corners and attempting to "hack" your way into compliance c...
Jaap Koster
CEO / Senior GxP Consultant
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